Study of Electrical Impedance Myography (EIM) in ALS

This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance
myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will
be studied:

1. Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal,
motor-predominant syndromes;

2. Track EIM progression over time and determine the best summary EIM measure that could
serve as an endpoint in future clinical trials and individual patient care; and,

3. Determine whether EIM progression is predictive of a combined outcome of survival and
progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held
Dynamometry (HHD) and Vital Capacity (VC) measures.

Early ALS Inclusion Criteria:

- Sporadic or familial ALS (as defined by revised El Escorial criteria)

- Onset of weakness or spasticity due to ALS ≤ 36 months prior to the
Screening/Baseline Visit.

- Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age

Early ALS Exclusion Criteria:

- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of active
substance abuse within the prior year.

ALS Disease Mimics Inclusion Criteria:

- Diagnosis of one of the following:

a. Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii.
Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness
involving more than one extremity or more than a single myotome if restricted to one
extremity.

iv. Multiple peripheral mononeuropathies with clinical weakness v. Charcot-Marie-Tooth
Disease vi. Any condition that produces generalized or localized weakness without
concomitant sensory symptoms, including myasthenia gravis or myopathy, that the evaluating
physician deems mimics ALS.

b. Pure Upper Motor Neuron Disease (UMND) mimics: i. Cervical myelopathy ii. Multiple
sclerosis iii. Hereditary spastic paraparesis

ALS Disease Mimics Exclusion Criteria:

- Diagnosis of possible, probable, probable-laboratory supported, or definite ALS

- Presence of positive family history of ALS.

- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of
active substance abuse within the prior year.

Healthy Volunteer Inclusion Criteria:

- Absence of a known neurological disorder.

Healthy Volunteer Exclusion Criteria:

- History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative
disease.

- Presence of positive family history of ALS.

- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of
active substance abuse within the prior year.

*Please note that this is not a complete listing on all eligibility criteria.*